Type 1 DiabetesNCT04474535
C-peptide Correlation With Microvascular Complications in T1DM
An observational study of Type 1 Diabetes and C-peptide, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Type 1 Diabetes, C-peptide, Diabetes Complications
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 3 Mar 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Consecutive patients with type 1 diabetes followed in our Diabetes outpatient clinic
Who may be able to join
- Type 1 diabetes
- Informed consent form
Who cannot join
- Known macrovascular complications
- Known serious microvascular complications
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, 11527
Alexandros Kokkinos, MD, PhD, +302132061248, akokkinos@med.uoa.gr
About this study
Official title: Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus
The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.
Read the detailed description
The study will include approximately 200 patients, male and female, with DM1 who are being followed in the outpatient diabetic clinic of our hospital.
Each patient will visit the Research Laboratory of the Diabetes Centre of our Department. The visit will take place in the morning in a fasting state of about 12 hours. Demographic data will be recorded along with the patients' habits, lifestyle, current medication and complete medical history of concomitant diseases.
This will be followed by anthropometric measurements (weight, height, BMI) and afterwards blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and lipids. Part of each blood sample will be collected in tubes containing EDTA to determine fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a morning urine sample by calculating urinary albumin to creatinine ratio (ACR).
The functionality of the heart's autonomic nervous system will be assessed through the use of heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing from the supine to the standing position will also be recorded. Subsequently, the distensibility of the large vessels will be determined, by calculating the conduction velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity (PWV)).
Finally, a full transthoracic echocardiographic study will be carried out to assess functionality, systolic and diastolic, of the left ventricle (LV).
All data will be recorded in an electronic database for statistical processing.
- Conditions
- Type 1 Diabetes, C-peptide, Diabetes Complications
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide concentrations
Concentrations of plasma c-peptide in the fasting condition
Measured: 1 day
Microvascular complications
Presence of microvascular complications
Measured: 1 day
Macrovascular complications
Presence of macrovascular complications
Measured: 1 day
Secondary outcomes (1)
Association between c-peptide and complications
Positive or negative association between c-peptide concentrations and presence of microvascular or macrovascular diabetes complications
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start3 Mar 2020
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandros Kokkinos, National and Kapodistrian University of Athens
- Investigators
- Alexandros Kokkinos, Principal investigator, First Department of Propaedeutic Medicine, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474535
- Sponsor's protocol ID
- T1DM C-peptide
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04474535
- Acronym / sponsor ID
- T1DM C-peptide
- Conditions
- Type 1 Diabetes, C-peptide, Diabetes Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.
Detailed description
The study will include approximately 200 patients, male and female, with DM1 who are being followed in the outpatient diabetic clinic of our hospital.
Each patient will visit the Research Laboratory of the Diabetes Centre of our Department. The visit will take place in the morning in a fasting state of about 12 hours. Demographic data will be recorded along with the patients' habits, lifestyle, current medication and complete medical history of concomitant diseases.
This will be followed by anthropometric measurements (weight, height, BMI) and afterwards blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and lipids. Part of each blood sample will be collected in tubes containing EDTA to determine fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a morning urine sample by calculating urinary albumin to creatinine ratio (ACR).
The functionality of the heart's autonomic nervous system will be assessed through the use of heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing from the supine to the standing position will also be recorded. Subsequently, the distensibility of the large vessels will be determined, by calculating the conduction velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity (PWV)).
Finally, a full transthoracic echocardiographic study will be carried out to assess functionality, systolic and diastolic, of the left ventricle (LV).
All data will be recorded in an electronic database for statistical processing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with type 1 diabetes followed in our Diabetes outpatient clinic
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Informed consent form
Key exclusion criteria (2 listed)
- Known macrovascular complications
- Known serious microvascular complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
C-peptide concentrations
Time frame: 1 day
Concentrations of plasma c-peptide in the fasting condition
Microvascular complications
Time frame: 1 day
Presence of microvascular complications
Macrovascular complications
Time frame: 1 day
Presence of macrovascular complications
1 secondary outcome
Association between c-peptide and complications
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandros Kokkinos principal investigator
First Department of Propaedeutic Medicine, University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and C-peptide, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Kokkinos (+302132061248, rjd@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-peptide concentrations (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.